PCV-20 vaccination for adults during a short febrile illness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized Phase 4 trial, adults at increased risk for invasive pneumococcal disease who are hospitalized with a recent non-severe fever are assigned to receive PCV-20 either during the febrile episode (early) or after recovery (delayed). Antibody levels are measured and participants are monitored for vaccine-related adverse events to compare immune response and safety between the two timing strategies. The primary goal is to test non-inferiority of immune responses when vaccination occurs during a transient febrile illness versus delayed vaccination. The trial is conducted at university and regional hospitals in France and enrolls adults with specified comorbidities who have been hospitalized for more than 24 hours.

Why it matters

Who can join: the full rules

Inclusion criteria :

* History of body temperature ≥ 38°C measured at least twice prior to randomization (Randomization must be performed as soon as possible on a febrile patient or 72 hours after apyrexia at the latest)
* Having at least one comorbidity that defines patients as medium or high risk for pneumococcal invasive infection:

  * Medium risk: Cyanogenic congenital heart disease; chronic heart failure; chronic respiratory failure; chronic obstructive pulmonary disease; emphysema; severe asthma under chronic treatment; chronic renal failure; chronic liver disease; diabetes mellitus treated; Osteo-meningeal leak or cochlear implant; Age \> 65 years old.
  * High risk : Hypo or asplenic people; hereditary immunodeficiency syndromes; people living with HIV; solid organ transplanted; People under immunosuppressors (corticosteroids, biotherapy) for an auto-immune or an inflammatory chronic disease; patients with nephrotic syndrome
* Hospitalization for \> 24 hours long
* Social security affiliation
* Signed informed consent

Exclusion criteria :

* Patient unable to give informed consent
* Curators, wardship
* History of previous vaccination with PCV-7 or PCV-13 or PCV-20
* History of PPV-23 in the previous year
* Patient having received another vaccination within one month prior to inclusion or planning another vaccination in the month after inclusion except for Influenza vaccine.
* Patient with history of bone marrow transplantation
* Patient with haematological malignancies
* Patient under chemotherapy for solid tumor or with a history of chemotherapy in the past three months
* Patient treated with Rituximab currently or in the past 6 months
* Patient with Sequential Organ Failure Assessment (qSOFA ) score ≥ 2 at randomization (acute severe febrile illness)
* Patient hospitalized in an Intensive Care Unit
* Pregnancy
* Breastfeeding woman
* Recipients of polyclonal gammaglobulins in the past three months
* Inability to follow the protocol
* Bleeding disorder contra-indicating intramuscular injection according to the investigator
* History of allergy to PCV-20 or vaccine-related components.
* S. pneumoniae infection with laboratory confirmation (blood culture, culture from a sterile site, urinary or Cerebrospinal fluid antigens, sputum culture with \> 10\^7 colony forming unit (CFU)/mL) being the cause of the current hospitalization

Where it's running

• CHU de Saint-Etienne
  Saint-Etienne, France, France Recruiting
• Centre Hospitalier
  Annecy, France Not yet recruiting
• Centre Hospitalier Universitaire
  Besançon, France Not yet recruiting
• Centre Hospitalier
  Bordeaux, France Not yet recruiting
• Centre Hospitalier Universitaire
  Brest, France Not yet recruiting
• Centre Hospitalier
  Brest, France Not yet recruiting

Study contacts

• Principal investigator: Elisabeth BOTELHO-NEVERS, MD PhD — Centre Hospitalier Universitaire de Saint Etienne
• Study coordinator: Elisabeth BOTELHO-NEVERS, MD PhD
• Email: Elisabeth.Botelho-Nevers@chu-st-etienne.fr
• Phone: (0)477829234

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nasal immune responses in older adults with pneumococcal or viral respiratory infections

  This project will test whether nasal immune responses differ in adults 60–85 with pneumococcal pneumonia, older adults carrying pneumococcus without symptoms, and those with flu or RSV.

  Recruiting University Hospital, Geneva · Geneva · NCT06998251

• Evaluating a new pneumococcal vaccine in infants

  This study is testing a new pneumococcal vaccine for infants to see if it is safe and works as well as an existing vaccine when given with other routine shots.

  Recruiting Phase 3 Beijing Minhai Biotechnology Co., Ltd · Denpasar, Bali and 2 other locations · NCT06608199

• Identifying pathogens in febrile patients using gene expression

  This study is trying to find out if looking at gene responses in feverish patients can help doctors quickly tell if they have enteric fever or another infection, especially in places with limited resources.

  Recruiting University of Sheffield · Vellore · NCT04878549

• Vaccination safety and immune response in adults with HIV

  This study is testing how safe and effective meningococcal and pneumococcal vaccines are for adults with HIV who are on treatment.

  Recruiting Phase 4 Hvidovre University Hospital · Hvidovre · NCT04875819

• Evaluating the impact of pneumococcal vaccination on invasive infections in children

  This study is trying to see how well the pneumococcal vaccines are working to protect children from serious infections caused by pneumococcus.

  Recruiting Association Clinique Thérapeutique Infantile du val de Marne · Créteil · NCT04664556

• Understanding causes and outcomes of febrile illness in rural South and Southeast Asia

  This study is trying to find out what causes fevers and how they affect people living in rural areas of Laos, Myanmar, Thailand, and Bangladesh to help improve health care in those communities.

  Recruiting at 3 sites University of Oxford · Dhaka and 3 other locations · NCT04629053

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.